Argatroban Plus r-tPA for Posterior Circulation Infarction(AR-PCI)

November 12, 2018 updated by: Hui-Sheng Chen

Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic patients has been a hot topic in the world.

Recent studies have found that the combined application of argatroban and rt-PA in the treatment of acute anterior circulation infarction might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.

Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of acute posterior circulation infarction.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Liaoning
      • Shenyang, Liaoning, China, 10016
        • General Hospital of Shenyang Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-80 years old;
  2. Diagnosis of posterior circulation ischemic stroke;
  3. Time from onset to treatment ≤6 hours;
  4. NIHSS: 4-25;
  5. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

  1. mRS≥2;
  2. History of stroke within 3 months;
  3. History of intracranial hemorrhage;
  4. Suspected subarachnoid hemorrhage;
  5. Intracranial tumour, vascular malformation or arterial aneurysm;
  6. Major surgery within 1 month;
  7. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
  8. Platelet count < 105/mm3;
  9. Heparin therapy or oral anticoagulation therapy within 48 hours;
  10. Abnormal APTT;
  11. Thrombin or Xa factor inhibitor;
  12. Severe disease with a life expectancy of less than 3 months;
  13. Blood glucose < 50 mg/dL (2.7mmol/L);
  14. Patients who have received any other investigational drug or device within 3 months;
  15. Pregnancy;
  16. Researchers consider patients inappropriate to participate in the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Argatroban combined with rt-PA
Argatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%).
Active Comparator: rt-PA
Intravenous throbolysis with 0.9mg/kg rtPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of mRS (0-1)
Time Frame: 90±7 days
90±7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of mRS (0-2)
Time Frame: 90±7 days
90±7 days
Early neurological deterioration
Time Frame: 48 hours
4 or more increase in NIHSS
48 hours
the occurence of stroke
Time Frame: 90±7 days
90±7 days
symptomatic intracranial hemorrhage
Time Frame: 36 hours
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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